Anorexia NervosaNCT04213820
TMS and Body Image Treatment for Anorexia Nervosa
A study testing Transcranial magnetic stimulation, Body Image Intervention and Treatment as usual in people with Anorexia Nervosa, run by Region Östergötland at 1 site in Sweden.
Trial summary
To evaluate if TMS together with a body image intervention is an efficacious treatment for anorexia nervosa compared to treatment as usual. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Transcranial magnetic stimulation, Body Image Intervention and Treatment as usual
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 25 Sep 2019to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being enrolled as a patient at the eating disorder unit of the Child and adolescent psychiatric clinic and Psychiatric clinic in Linköping
- Having a DSM-5 diagnosis of anorexia nervosa, atypical anorexia (restrictive type)
- Being at least 18 years of age
- Having a BMI of 20 or under.
- Being free of psychotropic medications or on stable (at least three months on the same dose) medication.
Who cannot join
- Clinical diagnosis of schizophrenia or psychotic disorder
- Clinical diagnosis of bipolar disorder
- Alcohol/drug dependence
- Ongoing treatment with antipsychotics or tricyclic antidepressants
- Previous severe head injury
- Birth before 33 weeks of gestation
Show all 11Show fewer
- Hearing impairment
- Earlier epilepsy or seizures of other causes
- Having severe claustrophobia
- Being pregnant
- Having a cognitive disability
Trial locations and contacts
1 site in 1 country.
Rebecca Böhme, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Region Östergötland BUP-kliniken
Linköping, 581 85
Maria A Zetterqvist, PhD, +46 101034339, maria.zetterqvist@liu.se
Rebecca Böhme, PhD, rebecca.bohme@liu.se
About this study
Official title: TMS Treatment for Anorexia Nervosa: Effects on Body Image Processing and Clinical Outcome Measures
To evaluate if TMS together with a body image intervention is an efficacious treatment for anorexia nervosa compared to treatment as usual.
- Conditions
- Anorexia Nervosa
- Being tested
- Transcranial magnetic stimulation, Body Image Intervention, Treatment as usual
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
TMS (theta burst) will be administered consisting of bursts containing 3 pulses at 50 Hz and an intensity of 80% motor threshold repeated at 200 ms intervals (i.e., at 5 Hz) and a 10 s between burst triplet interval for a total for 190 s (600 pulses). The intervention will be given daily 5 times/week during 4 weeks.
Body Image InterventionBehavioural
Body image interventions delivered directly after TMS will include body exercises that target disturbed body image and psychoeducation about the body. Together with a therapist the participants with anorexia nervosa will explore and estimate their body size through feedback.
Treatment as usualBehavioural
Treatment as usual at the eating disorder unit, Child and adolescent psychiatric clinic and Psychiatric clinic is delivered during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Participants will receive treatment as usual at the eating disorder unit at the Child and adolescent psychiatric clinic and at the Psychiatric clinic during 4 weeks. Receives: Behavioral: Treatment as usual |
| TMS and body image intervention | Experimental | Participants will receive TMS and a body image intervention daily 5 times/week during 4 weeks Receives: Device: Transcranial magnetic stimulation; Behavioral: Body Image Intervention |
| sham TMS and body image intervention | Sham comparator | Participants will receive sham TMS and a body image intervention Daily 5 times/week during 4 weeks Receives: Behavioral: Body Image Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination Questionnaire (EDE-Q)
EDE-Q measures symptoms of eating disorder. It contains at total of 36 items. 23 of these are rated on a Likert scale between 0-6 and contains 4 subscales: Restraint (ranging from 0-30); Eating concern (ranging from 0-30); shape concern (ranging from 0-48); weight concern (ranging from 0-30). Higher scores indicating more difficulties with eating disorder. In addition, 11 open ended questions concern binge eating and compensating behaviors.
Measured: Change from baseline at 4 weeks and at 6 months
Body Attitude Test (BAT)
BAT measures attitudes toward one own body. It contains a total of 20 items that are rated on a Likert scale between 0-5. Total scores range from 0-100. Higher scores indicate more problems with body attitude.
Measured: Change from baseline at 4 weeks and at 6 months
Body Shape Questionnaire (BSQ)
BSQ measures dissatisfaction with one's own body/figure. It contains a total of 34 items, which are rated on a Likert scale ranging from 1-6. total scores range from 34-204, with higher scores indicating more dissatisfaction.
Measured: Change from baseline at 4 weeks and at 6 months
Figure Rating Scale
Figure Rating Scale measures body image and estimation of one's own body size. Each figure presents nine schematic silhouettes, ranging from extreme thinness (1) to extreme obesity (9). For research purposes, participants are asked to self-select the silhouette that best indicates his or her current body size (ranging from 1-9) and the silhouette that reflects his or her ideal body size (ranging from 1-9).
Measured: Change from baseline at 4 weeks and at 6 months
Body Mass Index (BMI)
Body Mass Index is a person's weight in kilograms divided by the square of height in meters and is an indication of under- or overweight in adults.
Measured: Change from baseline at 4 weeks and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start25 Sep 2019
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Zetterqvist, Region Östergötland
- Investigators
- Maria A Zetterqvist, PhD, Principal investigator, Region Östergötland/Linköping university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213820
- Sponsor's protocol ID
- 2019-02821
- Other IDs
- 2019
- Status last verified
- Aug 2023
- First submitted
- 27 Dec 2019
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS Treatment for Anorexia Nervosa: Effects on Body Image Processing and Clinical Outcome Measures
- ClinicalTrials.gov ID
- NCT04213820
- Acronym / sponsor ID
- 2019-02821
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate if TMS together with a body image intervention is an efficacious treatment for anorexia nervosa compared to treatment as usual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Treatment as usualParticipants will receive treatment as usual at the eating disorder unit at the Child and adolescent psychiatric clinic and at the Psychiatric clinic during 4 weeks. |
| TMS and body image intervention | Experimental | Device: Transcranial magnetic stimulation, Behavioral: Body Image InterventionParticipants will receive TMS and a body image intervention daily 5 times/week during 4 weeks |
| sham TMS and body image intervention | Sham comparator | Behavioral: Body Image InterventionParticipants will receive sham TMS and a body image intervention Daily 5 times/week during 4 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being enrolled as a patient at the eating disorder unit of the Child and adolescent psychiatric clinic and Psychiatric clinic in Linköping
- Having a DSM-5 diagnosis of anorexia nervosa, atypical anorexia (restrictive type)
- Being at least 18 years of age
- Having a BMI of 20 or under.
- Being free of psychotropic medications or on stable (at least three months on the same dose) medication.
Key exclusion criteria (11 listed)
- Clinical diagnosis of schizophrenia or psychotic disorder
- Clinical diagnosis of bipolar disorder
- Alcohol/drug dependence
- Ongoing treatment with antipsychotics or tricyclic antidepressants
- Previous severe head injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationTMS (theta burst) will be administered consisting of bursts containing 3 pulses at 50 Hz and an intensity of 80% motor threshold repeated at 200 ms intervals (i.e., at 5 Hz) and a 10 s between burst triplet interval for a total for 190 s (600 pulses). The intervention will be given daily 5 times/week during 4 weeks. | Device | TMS and body image intervention |
| Body Image InterventionBody image interventions delivered directly after TMS will include body exercises that target disturbed body image and psychoeducation about the body. Together with a therapist the participants with anorexia nervosa will explore and estimate their body size through feedback. | Behavioural | TMS and body image intervention, sham TMS and body image intervention |
| Treatment as usualTreatment as usual at the eating disorder unit, Child and adolescent psychiatric clinic and Psychiatric clinic is delivered during 4 weeks | Behavioural | Treatment as usual |
Primary outcome
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Change from baseline at 4 weeks and at 6 months
EDE-Q measures symptoms of eating disorder. It contains at total of 36 items. 23 of these are rated on a Likert scale between 0-6 and contains 4 subscales: Restraint (ranging from 0-30); Eating concern (ranging from 0-30); shape concern (ranging from 0-48); weight concern (ranging from 0-30). Higher scores indicating more difficulties with eating disorder. In addition, 11 open ended questions concern binge eating and compensating behaviors.
Body Attitude Test (BAT)
Time frame: Change from baseline at 4 weeks and at 6 months
BAT measures attitudes toward one own body. It contains a total of 20 items that are rated on a Likert scale between 0-5. Total scores range from 0-100. Higher scores indicate more problems with body attitude.
Body Shape Questionnaire (BSQ)
Time frame: Change from baseline at 4 weeks and at 6 months
BSQ measures dissatisfaction with one's own body/figure. It contains a total of 34 items, which are rated on a Likert scale ranging from 1-6. total scores range from 34-204, with higher scores indicating more dissatisfaction.
Figure Rating Scale
Time frame: Change from baseline at 4 weeks and at 6 months
Figure Rating Scale measures body image and estimation of one's own body size. Each figure presents nine schematic silhouettes, ranging from extreme thinness (1) to extreme obesity (9). For research purposes, participants are asked to self-select the silhouette that best indicates his or her current body size (ranging from 1-9) and the silhouette that reflects his or her ideal body size (ranging from 1-9).
Body Mass Index (BMI)
Time frame: Change from baseline at 4 weeks and at 6 months
Body Mass Index is a person's weight in kilograms divided by the square of height in meters and is an indication of under- or overweight in adults.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Böhme, PhD contact
Maria A Zetterqvist, PhD principal investigator
Region Östergötland/Linköping university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation, Body Image Intervention and Treatment as usual in people with Anorexia Nervosa, run by Region Östergötland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria A Zetterqvist, PhD (+46 101034339, maria.zetterqvist@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination Questionnaire (EDE-Q) (time frame: Change from baseline at 4 weeks and at 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.